DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sivan et al. (Hereinafter Sivan) US-PG-PUB No. 2020/0245869.
Regarding claim 1, Sivan teaches
A hearing device (Fig. 2 shows an ear-wearable device (e.g. hearing aid….Para. [0220], Lines 11-12) 102A) comprising:
a memory (Fig. 2 shows a storage device 200….Para. [0053], lines 1-2);
an interface (a GUI of companion application 324…..Para. [0070], Lines 1-7);
a processing unit (Fig. 2 shows a processing circuit(s) 206); and
one or more sensors (Fig. 2 shows one or more of sensors 210);
wherein the processing unit (i.e. processing circuit(s) 206) is configured to:
obtain sensor data from the one or more sensors (processing circuit(s) 206 perform one or more aspects of the wellness evaluation system. Wellness evaluation system 602 receives a set of inputs 604. Inputs 604 include input 604A through input 604N. Inputs 604 may include data generated by one or more of sensors 210 of ear-wearable device(s) 102….Para. [0058], Lines 18-19 and Para. [0082], Lines 1-5);
determine, based on the sensor data, a health parameter indicative of a cognitive state of a user of the hearing device (companion application 324 may request data for calculating one or more of an achieved level of a wellness measure or other statistical data from ear-wearable device(s) 102 each time computing device 300 receives an indication of user input to navigate to the cognitive benefit section or body wellness score section of companion application 324…..Para. [0070], Lines 1-7);
determine whether the health parameter satisfies a first criterion indicative of a cognitive decline (outputs 606 of wellness evaluation system 602 may provide information about the user of ear-wearable device(s) 102 to one or more third-parties. In some examples, the provided information may inform the third-parties of signs of cognitive and/or physical decline….Para. [0089], Lines 1-6); and
in accordance with the health parameter satisfying the first criterion, cause the interface to provide a health representation associated with the cognitive state (Historical data 326 may comprise a database for storing historic data related to cognitive benefit. For example, companion application 324 may store, in historical data 326, brain wellness scores, body wellness scores, sub-component values, data from ear-wearable device(s) 102, and/or other data. Companion application 324 may retrieve data from historical data 326 to generate a GUI for display of past levels of one or more wellness measures of the user of ear-wearable device(s) 102….Para. [0072], Lines 1-10).
Regarding claim 2, Sivan teaches
The hearing device according to claim 1, wherein the one or more sensors comprise a microphone or provision of microphone input data (Microphone(s) 208 detect incoming sound and generate electrical signal(s) (e.g., analog or digital electrical signal(s)) representing the incoming sound….Para. [0055], Lines 2-4), and wherein the health parameter is based on the microphone input data (In a least one example, wellness evaluation system 602 may differentiate the user's voice sounds from other peoples' voice sounds based on signals generated by directional microphones in ear-wearable device(s) 102…..Para. [0150], Lines 13-17).
Regarding claim 3, Sivan teaches
The hearing device according to claim 2, wherein the processing unit is configured to determine the health parameter by determining, based on the microphone input data, a first voice biomarker (For example, data preparation system 700 may process sound detected by ear-wearable device(s) 102 or another operatively connected microphone to generate a voice print. The voice print may comprise information that characterizes a voice of a person….Para. [0130], Lines 1-6).
Regarding claim 4, Sivan teaches
The hearing device according to claim 3, wherein the processing unit is configured to determine the first voice biomarker by determining one or more of: a linguistic parameter, an acoustic parameter, a verbal fluency parameter, a mumbling parameter, a voice pitch parameter, or a speech rhythm parameter (wellness evaluation system 602 may be trained to recognize patterns in communication patterns of the user, such as: fundamental frequency of voice, spectral distribution of voice formants, prosody patterns, communication content, mannerisms, and the like….Para. [0150], Lines 9-13).
Regarding claim 5, Sivan teaches
The hearing device according to claim 3, wherein the first voice biomarker is based on one or more of: a linguistic parameter, an acoustic parameter, a verbal fluency parameter, a mumbling parameter, a voice pitch parameter, or a speech rhythm parameter (wellness evaluation system 602 may be trained to recognize patterns in communication patterns of the user, such as: fundamental frequency of voice, spectral distribution of voice formants, prosody patterns, communication content, mannerisms, and the like….Para. [0150], Lines 9-13).
Regarding claim 6, Sivan teaches
The hearing device according to claim 1, wherein the one or more sensors comprise one or more physiological sensors for provision of physiological data, and wherein the health parameter is based on the physiological data (FIG. 2, sensors 210 also include one or more accelerometers 218, a heart rate sensor 222, a body temperature sensor 224, and an electroencephalography (EEG) sensor 226….Para. [0082], Lines 1-5).
Regarding claim 7, Sivan teaches
The hearing device according to claim 6, wherein the processing unit is configured to determine the health parameter by determining, based on the physiological data, a first physiological biomarker(Wellness evaluation system 602 receives a set of inputs 604. Inputs 604 include input 604A through input 604N. Inputs 604 may include data generated by one or more of sensors 210 of ear-wearable device(s) 102….Para. [0082], Lines 1-5).
Regarding claim 8, Sivan teaches
The hearing device according to claim 7, wherein the processing unit is configured to determine the first physiological biomarker by determining one or more of: a blood pressure parameter, a blood flow parameter, a heart rate parameter, a respiratory parameter, a temperature parameter, an oxygen parameter, or a brain activity parameter (sensors 210 also include a heart rate sensor 222, a body temperature sensor 224, and an electroencephalography (EEG) sensor 226….Para. [0052], Lines 1-4).
Regarding claim 9, Sivan teaches
The hearing device according to claim 7, wherein the first physiological biomarker is based on one or more of: a blood pressure parameter, a blood flow parameter, a heart rate parameter, a respiratory parameter, a temperature parameter, an oxygen parameter, or a brain activity parameter (sensors 210 also include a heart rate sensor 222, a body temperature sensor 224, and an electroencephalography (EEG) sensor 226….Para. [0052], Lines 1-4).
Regarding claim 13, Sivan teaches
The hearing device according to claim 1, wherein the one or more sensors comprise one or more of: an optical sensor (ear-wearable device(s) 102 are being used may include electrodes, optical sensors….Para. [0221], Lines 15-17).
Regarding claim 14, Sivan teaches
The hearing device according to claim 1, wherein the processing unit comprises machine learning circuitry configured to operate according to a machine learning model, wherein the processing unit is configured to determine the health parameter based on the sensor data using the machine learning model (determining, by the one or more processing circuits, based on output values produced by the MLM, whether a user of the ear-wearable device has potentially been subject to physical abuse….Para. [0238], Lines 4-10).
Regarding claim 15, Sivan teaches
The hearing device according to claim 1, wherein the health representation comprises information regarding a degree of cognitive decline of the user (In this example, a “brain wellness score,” which may correspond to an overall level of mental wellness of the user of ear-wearable device(s), may be based on one or more of the use score, the engagement score, the active listening score, and/or other types of scores or data. For instance, the “brain wellness score” may be the weighted sum of e.g., the use score, the engagement score, the active listening score and/or other types of scores or data…..Para. [0099], Lines 17-24).
Regarding claim 16, Sivan teaches
The hearing device according to claim 1, wherein the health representation comprises a cognitive score (In this example, a “brain wellness score,” which may correspond to an overall level of mental wellness of the user of ear-wearable device(s), may be based on one or more of the use score, the engagement score, the active listening score, and/or other types of scores or data. For instance, the “brain wellness score” may be the weighted sum of e.g., the use score, the engagement score, the active listening score and/or other types of scores or data…..Para. [0099], Lines 17-24).
Regarding claim 17, Sivan teaches
The hearing device according to claim 1, wherein the health representation comprises one or more of: a representation of a voice biomarker (wellness evaluation system 602 may be trained to recognize patterns in communication patterns of the user, such as: fundamental frequency of voice, spectral distribution of voice formants, prosody patterns, communication content, mannerisms, and the like….Para. [0150], Lines 9-13)
Regarding claim 18, Sivan teaches
The hearing device according to claim 1, wherein the processing unit comprises hardware (a hardware unit or provided by a collection of interoperative hardware units, including one or more processors…Para. [0269], Lines 8-10).
Regarding claim 19, Sivan teaches
The hearing device according to claim 1, wherein the processing unit comprises a processor (processing circuitry may include one or more processors…Para. [0268], Lines 5-10).
Regarding claim 20, this claim is rejected for the same reasons as claim 1 because the apparatus of claim 1 is able to perform the method steps of claim 20.
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
7. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sivan in view of Chen et al. (Hereinafter Chen) US-PG-PUB No. 2022/0273227.
Regarding claim 10, Sivan teaches all the features with respect to claim 1 as outlined above.
Sivan does not explicitly teach wherein the one or more sensors comprise one or more biokinetic sensors for provision of biokinetic data, and wherein the health parameter is based on the biokinetic data.
Chen teaches that the one or more sensors comprise one or more biokinetic sensors for provision of biokinetic data, and wherein the health parameter is based on the biokinetic data (the sensors 202 are configured to obtain the sensed biokinetic data 216 (e.g. motion activity or accelerometer data) which is further transmitted and stored in the collection component 204 as collected data 218 (Para. [0032]-[0034] and [0084]). Specifically, the collected data 218 is used to generate one or more digital biomarkers that are analyzed to detect a cognitive decline of the subject 104 (Para. [0034] and [0084]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Sivan’s hearing system to include sensors for measuring biokinetic data, as taught by Chen. The advantage of such modification will allow for determining if the patient is suffering from a cognitive decline based on the biomarkers which are extracted from the biokinetic data (e.g., motion activity or accelerometer data) (see Para. [0032]-[0034] and [0084] by Chen).
Regarding claim 11, the combination of Sivan and Chen teach all the features with respect to claim 10 as outlined above. Chen teaches that the processing unit is configured to determine the health parameter by determining, based on the biokinetic data, a first biokinetic biomarker (the sensors 202 are configured to obtain the sensed biokinetic data 216 (e.g. motion activity or accelerometer data) which is further transmitted and stored in the collection component 204 as collected data 218 (Para. [0032]-[0034] and [0084]). Specifically, the collected data 218 is used to generate one or more digital biomarkers that are analyzed to detect a cognitive decline of the subject 104 (Para. [0034] and [0084]).
Regarding claim 12, the combination of Sivan and Chen teach all the features with respect to claim 11 as outlined above. Chen teaches that the processing unit is configured to determine the first biokinetic biomarker by determining one or more of:
a motion parameter (the sensors 202 are configured to obtain the sensed biokinetic data 216 (e.g. motion activity or accelerometer data) which is further transmitted and stored in the collection component 204 as collected data 218 (Para. [0032]-[0034] and [0084]). Specifically, the collected data 218 is used to generate one or more digital biomarkers that are analyzed to detect a cognitive decline of the subject 104 (Para. [0034] and [0084]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELICA M MCKINNEY whose telephone number is (571)270-3321. The examiner can normally be reached 7AM-3PM EST M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fan Tsang can be reached at 571-272-7574. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANGELICA M MCKINNEY/Primary Examiner, Art Unit 2694
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